AstraZeneca Pharmaceuticals LP – FDA 483, Jul 22, 2022

An FDA inspection of AstraZeneca Pharmaceuticals LP's vaccine manufacturing facility in Philadelphia, PA, revealed significant deficiencies in aseptic processing procedures, environmental monitoring, and equipment design. The firm also failed to adequately investigate unexplained discrepancies and extend risk assessments to other affected batches. These observations indicate a need for improved controls to prevent microbiological contamination and ensure product quality.